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BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

Sponsor
Bardy Diagnostics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02133261
Collaborator
(none)
10
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jun 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. adhesive performance/durability [7 days]

      The study will evaluate adhesive performance/durability by evaluating the Signal Quality of ECG data on the subjects (5 men and 5 women) in accordance with the requirements of FDA's ECG Electrode Guidance (section 5.A.3)1 and the ANSI/AAMI EC-12 Disposable ECG electrode technical standard (sections 4.4 and 5.4)2.

    Secondary Outcome Measures

    1. human factors [7 days]

      Skin comfort or discomfort Device comfort Device stability and contact

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • cardiac patient volunteers (5 male and 5 female)
    Exclusion Criteria:

    • skin rash or infection over the sternum

    • Sternal incision within 3 months from the date of enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 EvergreenHealth Enumclaw Washington United States 98022

    Sponsors and Collaborators

    • Bardy Diagnostics, Inc.

    Investigators

    • Principal Investigator: Gene Trobaugh, MD, EvergreenHealth

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bardy Diagnostics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02133261
    Other Study ID Numbers:
    • 7 day study
    First Posted:
    May 8, 2014
    Last Update Posted:
    Jun 26, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Tissue Adhesions

    Study Results

    No Results Posted as of Jun 26, 2014